Senior QA Engineer - Cell & Gene Therapy Startup

Genentech; Hillsboro (OR); On-site; USD 93,000 - 173,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech Hillsboro is seeking a Senior Quality Assurance Engineer to provide daily Quality Oversight for site qualification, equipment validation, and computer system validation during critical start-up activities. The role serves as the QA and Regulatory SME ensuring cGMP alignment across local processes and automated systems.

The successful candidate will lead validation activities, review critical documentation, and defend the program during regulatory audits while collaborating with

Qualifications

• Bachelor's or Master's in Engineering/Life Sciences with 8+ years pharma/biopharma experience, or 6+ years with a Master's.
• Strong knowledge of cGMPs and regulatory expectations related to validation.
• Experience with site qualification, equipment and computer system validation.
• Ability to lead risk assessments and manage CAPAs within a validated system.

Responsibilities

• Provide day-to-day Quality Oversight for site qualification and validation activities.
• Review and approve Validation Master Plans, URS, Protocols, deviations, and summary reports.
• Collaborate with Engineering during build/deploy to define specs for production equipment.
• Maintain inspection readiness and defend validation programs during audits.
• Assess changes and approve CAPAs and risk logs; drive continuous improvement.

Skills

Quality Oversight

Regulatory Knowledge

CSV (Computer System Validation)

Automation & Systems Knowledge

Risk Assessment (PHA/FMEA/FTA)

Cross-functional Collaboration

Travel willingness

Education

Bachelor's degree in Engineering or Life Sciences

Master's degree in Engineering or Life Sciences

Tools

DeltaV/SCADA

Syncade MES

BAS

EBR

Pi Data historian

Job description

Genentech Hillsboro is seeking a Senior Quality Assurance Engineer to provide daily Quality Oversight for site qualification, equipment validation, and computer system validation during critical start-up activities. The role serves as the QA and Regulatory SME ensuring cGMP alignment across local processes and automated systems.

The successful candidate will lead validation activities, review critical documentation, and defend the program during regulatory audits while collaborating with